EP0651249A2 - Analysevorrichtung - Google Patents

Analysevorrichtung Download PDF

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Publication number
EP0651249A2
EP0651249A2 EP94308091A EP94308091A EP0651249A2 EP 0651249 A2 EP0651249 A2 EP 0651249A2 EP 94308091 A EP94308091 A EP 94308091A EP 94308091 A EP94308091 A EP 94308091A EP 0651249 A2 EP0651249 A2 EP 0651249A2
Authority
EP
European Patent Office
Prior art keywords
membrane
assay
liquid
absorbent material
analytical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP94308091A
Other languages
English (en)
French (fr)
Other versions
EP0651249A3 (de
Inventor
Michael John Gordon
James Weston
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cogent Diagnostics Ltd
Original Assignee
Cogent Diagnostics Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cogent Diagnostics Ltd filed Critical Cogent Diagnostics Ltd
Publication of EP0651249A2 publication Critical patent/EP0651249A2/de
Publication of EP0651249A3 publication Critical patent/EP0651249A3/de
Withdrawn legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0633—Valves, specific forms thereof with moving parts
    • B01L2400/0644—Valves, specific forms thereof with moving parts rotary valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs

Definitions

  • the present invention relates to an analytical device.
  • dipsticks having binding agents, eg antibodies specific for the analytes in the sample, immobilised at discrete locations on their surfaces.
  • dipsticks are sequentially contacted with liquid samples containing analyte and assay reagents.
  • the present invention provides an analytical device in which the flow of liquids across and through an assay membrane can be controlled. This can be achieved by providing a relatively movable barrier which in one configuration tends to block the flow of liquid through the assay membrane, thereby directing liquid across the assay membrane, while relative displacement of the barrier to a second configuration allows liquid to pass through the assay membrane. Additionally or alternatively, the assay membrane can be movable into and out of contact with absorbent material so that in one configuration in which the membrane is in contact with the absorbent material, liquids tend to be drawn through the membrane, while in a second configuration in which the membrane is held away from the absorbent material, liquids tend to flow across the membrane.
  • the present invention provides an analytical device for detecting analytes in a liquid sample comprising;
  • the present invention provides an analytical device for detecting analytes in a liquid sample comprising;
  • the device can also store the excess liquid sample and reagents introduced into it after they have contacted the assay membrane. This has the advantage that the device encapsulates all the biological waste material used in the assay, allowing this waste material to be safely disposed of.
  • the waste material is stored in absorbent material.
  • This is preferably provided with a sintered membrane on the surface through which the waste can pass.
  • the sintered membrane facilitates passage of liquids introduced into the device across the entire assay membrane, before they pass through the membrane to be stored in the absorbent material, which may act as a wick.
  • the liquid sample containing the analytes to be detected is whole blood, serum, plasma, saliva or urine.
  • saliva is preferred as the sample can be easily taken from patients.
  • a reactive area on the assay membrane comprises a binding agent, eg an antibody, immobilised on the assay membrane in a discrete location, eg a spot.
  • a binding agent eg an antibody
  • the present invention therefore allows for the assay of a plurality of analytes by immobilising a plurality of binding agents on the surface at discrete locations.
  • control locations can be included on the assay membrane for comparison with the reactive areas.
  • the housing of the assay device is cylindrical and is divided into cylindrical sections which are rotatable about the longitudinal axis of the device relative to each other.
  • a port in the device allows sample and reagents to be introduced onto the assay surface.
  • the barrier and assay membrane are conveniently planar, part-circular surfaces (eg each being semicircular) and are mounted on adjacent sections, with the assay membrane held between the barrier and the port. Both the barrier and assay membrane are held approximately parallel to each other and to the flat faces of the cylinder.
  • the barrier is made of a hydrophobic material.
  • the barrier in the first position the barrier lies adjacent and "eclipses" the assay membrane, preventing liquid sample passing through the assay membrane.
  • the sections on which the barrier and assay membrane are mounted are rotated relative to each other, with the result that the assay membrane and barrier are no longer in the eclipse relationship. This allows reagents to pass through the assay membrane without being blocked by the barrier.
  • adjacent sections of the housing contain the absorbent material and the assay membrane so that the rotation of the sections about the longitudinal axis of the device causes the membrane and absorbent material to move relative to each other, moving the assay membrane into or out of contact with the absorbent material.
  • one of the sections can be conveniently provided with grooves and the other with lugs adapted to locate in the grooves so that when the sections are rotated, the lugs and grooves guide the movement of the sections.
  • the membrane and the barrier or the membrane and absorbent material move relative to each other between the first and second positions as the sections are twisted by the user of the device.
  • the grooves can define the amount of rotation, eg 1/2 a turn, that is needed to change the device between configurations.
  • the grooves may be angled with respect to the longitudinal axis of the device so that the relative rotation of the sections causes the membrane to move into and out of contact with the absorbent material.
  • the present invention also includes a kit for carrying out an assay comprising an analytical device as described above, in combination with the reagents for carrying out the assay.
  • Figures 1 and 3 show an assay device 2 has a cylindrical housing which includes a round top cover portion 10 having a port 6 through which sample and reagents can be introduced and a second port or transparent portion 8 through which readings can be made.
  • the assay device has a semicircular hydrophobic barrier 14 mounted between a semicircular assay membrane 12 and a circular sintered membrane 16.
  • a matrix of absorbent material 18 under the sintered membrane 16 serves as a wick to draw liquid introduced into the device and may further serve to store waste reagents and sample.
  • the housing of the assay device 2 is divided into cylindrical sections with the assay membrane 12 and the hydrophobic barrier 14 mounted on adjacent sections. These sections are rotatable relative to one another about the longitudinal axis of the device.
  • the assay membrane 12 and hydrophobic barrier 14 are planar, semi-circular surfaces, and in a first position shown in figure 1, the hydrophobic barrier 14 is held eclipsed between the assay membrane 12 and the sintered membrane 16.
  • Figures 2 and 4 show plan views of the device showing reactive areas 20 of binding agent, in this case different antibodies (IgA, IgG and IgM) to bind rheumatoid factors, immobilised on the assay membrane 12 in a series of discrete spots. Also immobilised on the assay membrane 12 are positive 22 and negative 24 controls.
  • the reactive areas 20 and controls 22, 24 are arranged a common distance from the central axis of the device so that liquid sample and reagents introduced into the device flow an equal distance across the assay membrane 12 to reach them.
  • the top portion 10 of the device can be incrementally rotated relative to the rest of the device, allowing the spots to be individually viewed through the second port 8 in order to take the results of the assay.
  • the liquid sample is introduced into the device 2 through port 6 while it is in the position shown in figures 1 and 3.
  • the liquid sample contacts the assay membrane 12 directly under port 6 and flows outwards towards the reactive areas 20 and controls 22, 24. If the liquid sample is whole blood, red blood cells adhere to the assay membrane around the area of contact, while plasma containing the analytes can flow outwards towards the reactive areas 20 and controls 22, 24. This avoids the need for separating the cells from the plasma.
  • the liquid sample is prevented from passing through the assay membrane 12 by the hydrophobic barrier 14 eclipsed between the assay membrane 12 and the sintered membrane 16.
  • the section of the device on which the assay membrane 12 is mounted is rotated into the position shown in figures 3 and 4. In this position, the hydrophobic barrier 14 is no longer eclipsed between the assay membrane 12 and the sintered membrane 16.
  • a liquid for example a wash buffer
  • the sintered membrane 16 acts to draw reagent across the entire assay membrane 12, providing complete and even contact.
  • the liquid is then drawn through the sintered membrane 16 into the wick 18 which serves as a reservoir to store the waste reagents.
  • the device 2 is rotated back to the position shown in figures 1 and 2.
  • a conjugate can then be introduced into the device 2 and the device rotated into the position shown in figures 3 and 4 for further washing.
  • the device 2 is then rotated back into the position shown in figures 1 and 2.
  • substrates will then be added through port 6 to react with the analytes bound to the reactive areas 20 and produce a detectable result, eg a colour change.
  • coloured latex particles having antibody immobilised their surfaces can be added after a single washing step to produce a detectable result.
  • the results can be read by rotating the top portion 10 of the device until the second port 8 is above the reactive area or control area to be read. This has the advantage that each reading is made separately, avoiding any confusion from adjacent reactive areas or controls.
  • the analytical device 2 can be disposed of as a single unit encapsulating the sample and all the reagents used in the assay.
  • Figures 5 and 6 show an assay device 2 generally similar to the device of figures 1 to 4, except that it does not have a movable hydrophobic barrier to control the flow of liquids through and across the assay membrane 12.
  • the flow of liquid introduced through port 6 is controlled by bringing the assay membrane 12 into and out of contact with the absorbent wick 18. This is achieved by providing lugs 26 on the inside surface of the top section 28 of the device 2 on which the assay membrane 12 is carried and grooves 30 on the outer surface of the lower section 32 containing the absorbent material (wick) 18.
  • the grooves 30 are angled with respect to the longitudinal axis of the device and each groove runs around half of the circumference of the housing.
  • the two sections 28, 32 can be rotated relative to each other through 180°, bringing the membrane 12 into or out of contact with the absorbent material 18, as required for carrying out an assay.
  • the grooves 30 and lugs 26 also help to define the amount of rotation needed to change the device between configurations, making the device easy to use and helping to ensure that each assay is carried out under a fixed set of conditions.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
EP94308091A 1993-11-03 1994-11-02 Analysevorrichtung. Withdrawn EP0651249A3 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9322650 1993-11-03
GB939322650A GB9322650D0 (en) 1993-11-03 1993-11-03 Analytical device

Publications (2)

Publication Number Publication Date
EP0651249A2 true EP0651249A2 (de) 1995-05-03
EP0651249A3 EP0651249A3 (de) 1997-08-20

Family

ID=10744565

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94308091A Withdrawn EP0651249A3 (de) 1993-11-03 1994-11-02 Analysevorrichtung.

Country Status (2)

Country Link
EP (1) EP0651249A3 (de)
GB (1) GB9322650D0 (de)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2342443A (en) * 1998-10-02 2000-04-12 Abp Diagnostics Limited Immunoassay device
WO2000024927A1 (de) * 1997-10-23 2000-05-04 Qiagen Gesellschaft Mit Beschränkter Haftung Verfahren und mittel zur isolierung und reinigung von nukleinsäuren an oberflächen
EP1419387A1 (de) * 2001-08-20 2004-05-19 Proteome Systems Intellectual Property Pty Ltd. Verfahren und vorrichtung zum diagnostischen testen
US7875435B2 (en) 2001-12-12 2011-01-25 Proteome Systems Ltd Diagnostic testing process

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989006799A1 (en) * 1988-01-21 1989-07-27 Boehringer Mannheim Corporation Method for determination of a component of a sample and apparatus therefor
WO1990005906A1 (en) * 1988-11-14 1990-05-31 Idexx Corporation Dual absorbent analyte detection
US4938927A (en) * 1982-01-08 1990-07-03 Environmental Diagnostics, Inc. Rotary fluid manipulator
EP0418765A2 (de) * 1989-09-21 1991-03-27 Becton, Dickinson and Company Testgerät mit Fliesskontrolleinrichtung
WO1991019567A1 (en) * 1990-06-15 1991-12-26 Chiron Corporation Self-contained assay assembly and apparatus

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4938927A (en) * 1982-01-08 1990-07-03 Environmental Diagnostics, Inc. Rotary fluid manipulator
WO1989006799A1 (en) * 1988-01-21 1989-07-27 Boehringer Mannheim Corporation Method for determination of a component of a sample and apparatus therefor
WO1990005906A1 (en) * 1988-11-14 1990-05-31 Idexx Corporation Dual absorbent analyte detection
EP0418765A2 (de) * 1989-09-21 1991-03-27 Becton, Dickinson and Company Testgerät mit Fliesskontrolleinrichtung
WO1991019567A1 (en) * 1990-06-15 1991-12-26 Chiron Corporation Self-contained assay assembly and apparatus

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000024927A1 (de) * 1997-10-23 2000-05-04 Qiagen Gesellschaft Mit Beschränkter Haftung Verfahren und mittel zur isolierung und reinigung von nukleinsäuren an oberflächen
JP2008245649A (ja) * 1997-10-23 2008-10-16 Qiagen Gmbh 表面における核酸の単離及び精製のための方法並びに手段
EP2251440A3 (de) * 1997-10-23 2011-11-16 Qiagen GmbH Verfahren und Mittel zur Isolierung und Reinigung von Nukleinsäuren an Oberflächen
GB2342443A (en) * 1998-10-02 2000-04-12 Abp Diagnostics Limited Immunoassay device
EP1419387A1 (de) * 2001-08-20 2004-05-19 Proteome Systems Intellectual Property Pty Ltd. Verfahren und vorrichtung zum diagnostischen testen
EP1419387A4 (de) * 2001-08-20 2005-12-14 Proteome Systems Intellectual Verfahren und vorrichtung zum diagnostischen testen
US7205159B2 (en) 2001-08-20 2007-04-17 Proteome Systems Intellectual Property Pty Ltd. Diagnostic testing process and apparatus
US7875435B2 (en) 2001-12-12 2011-01-25 Proteome Systems Ltd Diagnostic testing process
US8067246B2 (en) 2001-12-12 2011-11-29 Tyrian Diagnostics Limited Diagnostic testing process

Also Published As

Publication number Publication date
EP0651249A3 (de) 1997-08-20
GB9322650D0 (en) 1993-12-22

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